The medical device or IVD register must, in respect of a registered medical device or IVD, contain the following information:
| (a) |
The name and group or family and the make and model, where applicable, of the medical device or IVD; |
| (b) |
the registration number allocated to the medical device or IVD; |
| (c) |
in the case of a combination device, the name and quantity of the scheduled substances or biological substances in the medical device; |
| (d) |
the intended purpose or use of the medical device or IVD; |
| (e) |
the name of the holder of the certificate of registration; |
| (f) |
the name and address of the original manufacturer; |
| (g) |
the date of registration of the medical device or IVD; |
| (h) |
the conditions of registration of the medical device or IVD; |
| (i) |
the class of medical device or IVD; and |
| (j) |
the nomenclature system code allocated to the medical device or IVD. |
Statistics Act, 1999
